Scalp Nerve Block and Opioid Consumption in Brain Surgery

Phase 4

Completed

• Conditions: Brain Tumour
• Interventions: Drug: Scalp block with 0.5% plain Marcaine; Drug: Scalp block with 0.9% normal saline

• Registration Number: NCT02057367
• Lead Sponsor: Chiang Mai University

Brief Summary

Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

Detailed Description

Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

A Prospective Randomized Double Blind Control

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-07
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients who have supratentorial brain tumor
2. Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position
3. Patients have been general anesthetized with endotracheal intubation and control ventilation
4. Patients who have provided consent for the participation in the research and for the use of their medical record in research

Exclusion Criteria

1. Pregnant patients
2. Patients who have a history of local anesthetic allergy and/ or anaphylaxis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scalp block with 0.5% plain marcaine	Scalp block with 0.5% plain Marcaine	Anterior scalp block with 0.5% plain Marcaine 20 ml.
Scalp block with 0.9% normal saline	Scalp block with 0.9% normal saline	Anterior scalp block with 0.9% normal saline 20 ml.

Primary Outcome Measures

Name	Time	Method
Intraoperative opioid consumption	During the supratentorial craniotomy surgery	The overall intravenous fentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.

Secondary Outcome Measures

Name	Time	Method
Heart rate change	within 5 minutes after skull pin insertion	The maximal heart rate within the first 5 minutes after skull pin insertion will be recorded.; The heart rate change from baseline level will be calculated. The unit is beats per minute.
systolic blood pressure change	within 5 minutes after skull pin insertion	The maximal systolic blood pressure within the first 5 minutes after skull pin insertion will be recorded.; The systolic blood pressure change from baseline will be calculated. The unit is mmHg.

Trial Locations

Locations (1)

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand